N/A
Completed N=5
A Translational Approach to Gitelman Syndrome
Gitelman Syndrome
Source: ClinicalTrials.gov NCT00822107 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Chloriuretic Response to a Thiaizde — 1.23 fractional chloride excretion
Summary
This study will test the response to a single dose of thiazide diuretic as a diagnostic test for Gitelman syndrome. Individuals with hypokalemic alkalosis will be enrolled. After a baseline study, they will have the response to 50 mg hydrochlorothiazide on fractional chloride excretion examined.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chloriuretic Response to a Thiaizde |
1.23 | — |
Eligibility Criteria
Inclusion Criteria
- Institutional Review Board (IRB) approved written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization as per national regulations, must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- Subject is between the ages of 21 and 60.
- Female subjects of child bearing potential must have a negative urine pregnancy test at the screening visit (Study Visit 1) and must agree to maintain effective birth control during the study.
- Subjects who are referred to Dr. Ellison for evaluation of normotensive hypokalemia of unknown etiology
Exclusion Criteria
- Subject has known allergy to thiazide or sulfonamide medications
- Subject is pregnant or lactating.
- Subject has major systemic illnesses that affect potassium regulation through pathology or pharmacologic treatment. This category includes:
- Hypertension
- Requiring regular pharmacological control
- History of blood pressure greater than 140mmHg systolic and 90mmHg diastolic
- Congestive heart failure
- Cirrhosis of the liver
- Subject has documented kidney disease resulting in anuria, proteinuria or abnormal urinalysis, or requiring dialysis for treatment.
Data sourced from ClinicalTrials.gov (NCT00822107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.